The following data is part of a premarket notification filed by Intersection Medical, Inc. with the FDA for Imed-z Fluid Status Monitor.
| Device ID | K142503 |
| 510k Number | K142503 |
| Device Name: | IMED-Z FLUID STATUS MONITOR |
| Classification | Plethysmograph, Impedance |
| Applicant | INTERSECTION MEDICAL, INC. 1808 ASTON AVE STE 120 Carlsbad, CA 92008 -7364 |
| Contact | Warren Craycroft |
| Correspondent | Warren Craycroft INTERSECTION MEDICAL, INC. 1808 ASTON AVE STE 120 Carlsbad, CA 92008 -7364 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-05 |
| Decision Date | 2015-06-05 |
| Summary: | summary |